Diabetes Mellitus, Type 2Phase 4NCT00349986
LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus
A Phase 4 study testing Insuline glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Hungary.
Trial summary
The rationale of the study is to determine: the first dose and the titration of basal insulin the exact daily time administration of basal insulin in poorly controlled type II diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insuline glargine
- How many people
- 4 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2006to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus
- Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
- BMI >25 kg/m2 , <30 kg/m2
- HbA1c value >7.0%, <9.0% within one month
Who cannot join
- Type 1 Diabetes Mellitus
- Known malignancy
- Drug or alcohol abuse
- Severe liver disease
- Renal failure (se Creatinine > 150 micro mol/l)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients
The rationale of the study is to determine:
- the first dose and the titration of basal insulin
- the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insuline glargine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insuline glargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HgbA1c measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2007
Why it stopped: prematurely terminated due to loss of interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- László Erős, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349986
- Sponsor's protocol ID
- HOE901_4059
- Status last verified
- Dec 2009
- First submitted
- 7 Jul 2006
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients
- ClinicalTrials.gov ID
- NCT00349986
- Acronym / sponsor ID
- HOE901_4059
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: prematurely terminated due to loss of interest
- Enrolment
- 4 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale of the study is to determine:
- the first dose and the titration of basal insulin
- the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 Diabetes Mellitus
- Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
- BMI >25 kg/m2 , <30 kg/m2
- HbA1c value >7.0%, <9.0% within one month
Key exclusion criteria (6 listed)
- Type 1 Diabetes Mellitus
- Known malignancy
- Drug or alcohol abuse
- Severe liver disease
- Renal failure (se Creatinine > 150 micro mol/l)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insuline glargine | Drug | – |
Primary outcome
HgbA1c measurement
Results and safety
The study was stopped early (reason given: prematurely terminated due to loss of interest). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
László Erős, MD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insuline glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: prematurely terminated due to loss of interest). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HgbA1c measurement. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2009; AzTrials last refreshed its copy on 7 Nov 2026.